Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Lower Limb Amputation Above Knee (Injury) Clinical Trial

— ASCENT K2  

Official title:

Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04784429
• Other study ID #: OB113
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Otto Bock Healthcare Products GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Description:

Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: December 31, 2026
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Unilateral transfemoral or knee disarticulation amputation

• Received prosthesis between 4 - 24 months prior

• Currently uses prosthesis

• K2 ambulator status

• Able to speak English or Spanish language

• Age = 65 years at Baseline Assessment (one month after enrollment)

• Minimum Socket Comfort Score (SCS) of 6/10

Exclusion Criteria:

• Upper limb involvement

• Individuals = 275 lbs

• Unable to provide informed consent

• History of acute or chronic residual limb breakdown

• History of 2 or more socket adjustments or replacements in the past 6 months

• Amputation of the contralateral limb

• Active malignancy

• Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel

• Patient unable or unwilling to follow study procedures

• Pregnant women, institutionalized persons, and children

Related Conditions & MeSH terms

• Congenital Amputation of Lower Limb
• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation Knee

Intervention

Device:
• Kenevo or C-Leg 4
Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s.
• Non microprocessor controlled knee (NMPK)
NMPK consistent with current standards of care

Locations

Country	Name	City	State
United States	Hanger Clinic - 607 N. Jefferson Street	Albany	Georgia
United States	Hanger Clinic - 715 Dr Martin Luther King Jr Ave NE Ste	Albuquerque	New Mexico
United States	Hanger Clinic - 11346 S Cicero Ave	Alsip	Illinois
United States	Hanger Clinic - 305 E Greenville St	Anderson	South Carolina
United States	Hanger Clinic - 4849 Lonetree Way, STE B	Antioch	California
United States	Hanger Clinic - 1010 Stillwater Ave, Ste 106	Bangor	Maine
United States	Hanger Clinic - 8522 Summa Ave	Baton Rouge	Louisiana
United States	Hanger Clinic - 4505 Utica Ridge Rd	Bettendorf	Iowa
United States	Hanger Clinic - 225 South Michigan Ave Suite B	Big Rapids	Michigan
United States	Hanger Clinic - 1119 Professional Park Drive	Brandon	Florida
United States	Hanger Clinic - 3065 William Street, Suite 205	Cape Girardeau	Missouri
United States	Hanger Clinic - 866 5th Ave SE	Cedar Rapids	Iowa
United States	Hanger Clinic - 4407 MacCorkle Ave SE	Charleston	West Virginia
United States	Hanger Clinic - 2219 E. 7th St.	Charlotte	North Carolina
United States	Hanger Clinic - 2835 N Sheffield Ave, Ste 301	Chicago	Illinois
United States	Hanger Clinic - 1739 Blanding St.	Columbia	South Carolina
United States	Hanger Clinic - 8000 State Highway 242, Suite 100	Conroe	Texas
United States	Hanger Clinic - 1050 Buford Rd, Ste 106	Cumming	Georgia
United States	Hanger Clinic - 3910 Gaston Ave STE 150	Dallas	Texas
United States	Hanger Clinic - One Elizabeth Place Suite 300	Dayton	Ohio
United States	Hanger Clinic - 1400 Mason Ave. Suite 103	Daytona Beach	Florida
United States	Hanger Clinic - 330 Laurel St. #1300	Des Moines	Iowa
United States	Hanger Clinic - 321 Westgate Pkwy	Dothan	Alabama
United States	Hanger Clinic - 423 Normal St.	East Stroudsburg	Pennsylvania
United States	Hanger Clinic - 660 Wessel Drive	Fairfield	Ohio
United States	Hanger Clinic - 1743 Creekside, Suite #110	Folsom	California
United States	Hanger Clinic - 804 Kenyon Road	Fort Dodge	Iowa
United States	Hanger Clinic - 12591 Creekside Lane	Fort Myers	Florida
United States	Hanger Clinic - 3501 S Mercy Road	Gilbert	Arizona
United States	Hanger Clinic - 65 Medical Park Drive, Suite 3	Helena	Montana
United States	Hanger Clinic - 221 W. Main Street	Inverness	Florida
United States	Hanger Clinic - 779 W. Forest Ave	Jackson	Tennessee
United States	Hanger Clinic - 502 Princeton Rd	Johnson City	Tennessee
United States	Hanger Clinic - 2340 E. Meyer Blvd, Building 2, Suite 394	Kansas City	Missouri
United States	Hanger Clinic - 5027 Green Bay Rd, Suite 124	Kenosha	Wisconsin
United States	Hanger Clinic - 320 West Water St, Suite D	Kerrville	Texas
United States	Hanger Clinic - 308 East Oak Street	Kissimmee	Florida
United States	Hanger Clinic - 6300 Baum Dr	Knoxville	Tennessee
United States	Hanger Clinic - 3440 Losey Blvd S	La Crosse	Wisconsin
United States	Hanger Clinic - 940 Kaliste Saloom	Lafayette	Louisiana
United States	Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place	Lakewood	Colorado
United States	Hanger Clinic - 7250 Peak Drive, STE 120	Las Vegas	Nevada
United States	Hanger Clinic - 100 Erdman Way, STE 100	Leominster	Massachusetts
United States	Hanger Clinic - 1001 S 70th St Ste 110	Lincoln	Nebraska
United States	Hanger Clinic - 1516 Hudson Street, Suite 105	Longview	Washington
United States	Hanger Clinic - 778 Riverside Drive	Macon	Georgia
United States	Hanger Clinic - 266 Cherokee Professional Park	Maryville	Tennessee
United States	Hanger Clinic - 6001 Landerhaven Dr Ste A	Mayfield Heights	Ohio
United States	Hanger Clinic - 7 North Bellevue Blvd	Memphis	Tennessee
United States	Hanger Clinic - 1903 23rd Ave	Meridian	Mississippi
United States	Hanger Clinic - 100 Milk Street, Suite 120	Methuen	Massachusetts
United States	Hanger Clinic - 1551 Bond Street, Suite 111	Naperville	Illinois
United States	Hanger Clinic - 6270 Naples Blvd, Bldg 1	Naples	Florida
United States	Hanger Clinic - 704 Thimble Shoals Blvd. Suite 400-B	Newport News	Virginia
United States	Hanger Clinic - 401 Harrison Street	Oak Park	Illinois
United States	Hanger Clinic - 17500 Burke St, Suite 100	Omaha	Nebraska
United States	Hanger Clinic - 9109 Blondo Street	Omaha	Nebraska
United States	Hanger Clinic - 824 Creighton Road	Pensacola	Florida
United States	Hanger Clinic - 3816 N. 7th St.	Phoenix	Arizona
United States	Hanger Clinic - 4045 E Bell Rd	Phoenix	Arizona
United States	Hanger Clinic - 959 Brighton Ave.	Portland	Maine
United States	Hanger Clinic - 5809 West Norfolk Road	Portsmouth	Virginia
United States	Hanger Clinic - 961 Matley Ln Ste 100	Reno	Nevada
United States	Hanger Clinic - 401 SW 41st ST	Renton	Washington
United States	Hanger Clinic - 4821 Old National Road East, Suite A	Richmond	Indiana
United States	Hanger Clinic - 1882 Winton Road South, Suite 6	Rochester	New York
United States	Hanger Clinic - 4001 N Mays St. Ste 1200	Round Rock	Texas
United States	Hanger Clinic - California - 1248 32nd St	Sacramento	California
United States	Hanger Clinic - 200 Southpark Blvd, Suite 209	Saint Augustine	Florida
United States	Hanger Clinic - 150 St Peters Centre Blvd	Saint Peters	Missouri
United States	Hanger Clinic - 645 East Crawford St	Salina	Kansas
United States	Hanger Clinic - 2785 East 3300 South	Salt Lake City	Utah
United States	Hanger Clinic - 1139 S.E. Military Dr., Suite 111	San Antonio	Texas
United States	Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201	Somersworth	New Hampshire
United States	Hanger Clinic - 1985 Main Street	Springfield	Massachusetts
United States	Hanger Clinic - 355 W Carpenter St.	Springfield	Illinois
United States	Hanger Clinic - 1215A Merchant Way	Statesboro	Georgia
United States	Hanger Clinic - 1400 College St, Ste 7	Sulphur Springs	Texas
United States	Hanger Clinic - 13925 Meeker Blvd, Suite 5	Sun City West	Arizona
United States	Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7	Torrance	California
United States	Hanger Clinic - 1001 Cromwell Bridge Rd, Suite 108	Towson	Maryland
United States	Hanger Clinic - 502 Council Circle	Tupelo	Mississippi
United States	Hanger Clinic - 820 S Akers St, Ste 230	Visalia	California
United States	Hanger Clinic - 17490 Hwy 3 Unit 100A	Webster	Texas
United States	Hanger Clinic - 5502 Brush Hollow Rd.	Westbury	New York
United States	Hanger Clinic - 410 N. Hillside, Suite 100	Wichita	Kansas
United States	Hanger Clinic - 1399 Westgate Center Dr	Winston-Salem	North Carolina
United States	Hanger Clinic - 215 First Street North, Suite 300A	Winter Haven	Florida
United States	Hanger Clinic - 40 Berkshire Ct STE 2	Wyomissing	Pennsylvania
United States	Hanger Clinic - 1215 Plumas Street, Suite 1000	Yuba City	California

Sponsors (2)

Lead Sponsor	Collaborator
Otto Bock Healthcare Products GmbH	Hanger Clinic: Prosthetics & Orthotics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.	12 months
Primary	Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.	5 years
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).	12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.	12 months
Secondary	12-month fall count from bi-weekly fall journal	On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality.	12 months
Secondary	Average daily step counts	Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.	12 months
Secondary	Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.	3 years
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).	5 years
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.	5 years
Secondary	10-meter Walk Test (10mWT)	The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.	5 years
Secondary	Timed Up and Go (TUG)	The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.	5 years
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.	3 years
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.	3 years
Secondary	10-meter Walk Test (10mWT)	The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.	3 years
Secondary	Timed Up and Go (TUG)	The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.	3 years